PVmed Receives FDA 510(k) Clearance for PV-iCurve Pro

by PVmed
Date: November 10, 2026

Cancer care software developer PVmed has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for PV-iCurve Pro, its intelligent contouring solution for radiation therapy.

PV-iCurve Pro automatically contours CT images as soon as they arrive, taking much of the manual work out of one of the most time-consuming steps in radiation therapy planning. Clinicians then refine the results directly on the same platform.

PV-iCurve Pro FDA 510(k) Cleared - Intelligent Contouring Solution for Radiation Therapy

Key features include:

  • Broad anatomical coverage: Auto-contouring of more than 200 structures on CT, including organs at risk and lymph node regions across the head and neck, chest, abdomen and pelvis.
  • Unattended workflow: Preset templates can contour images automatically as soon as they arrive and send the results on to treatment planning systems.
  • Comprehensive editing tools: Pen, brush, smart interpolation, thresholding, margin expansion and a Boolean structure calculator for refining contours and creating planning structures.
  • Multi-modality image fusion: Rigid and deformable registration of CT and MR images with a fusion verification tool, plus viewing and editing on CT, CBCT, MR and PET data.
  • Access from anywhere in the hospital: Browser-based deployment lets clinicians review and edit contours from any terminal in the hospital, with DICOM 3.0 connectivity to PACS and treatment planning systems and role-based user permissions.

PVmed’s solutions are used in more than 800 hospitals and have supported the care of more than 1.1 million patients. With FDA establishment registration and device listing now complete, the company is ready to offer PV-iCurve Pro to radiation oncology departments in the U.S.

For more information, contact contactus@pvmedtech.com.


About PVmed

Founded in 2017, PVmed develops software for radiation therapy and surgical oncology, with applications spanning auto-contouring, image fusion, adaptive radiotherapy assessment and 3D surgical reconstruction.

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